Grosse-Kreul Dorothea, Allen Crystal, Kalicinsky Chrystyna, Keith Paul K
School of Immunology and Microbial Sciences, Department of Immunological Medicine and Allergy, King's College Hospital NHS Foundation Trust, King's Health Partners, London, UK.
Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Allergy Asthma Clin Immunol. 2024 Oct 4;20(1):52. doi: 10.1186/s13223-024-00914-7.
Primary immunodeficiency diseases (PIDs), also referred to as inborn errors of immunity, constitute a group of genetic conditions that affect the immune system. The current standard of care for patients with PIDs is lifelong immunoglobulin replacement therapy, delivered by intravenous (IVIG) or subcutaneous (SCIG) infusion. Immune globulin subcutaneous (human) 20% solution stabilized with glycine (Ig20Gly) is indicated as a replacement therapy for PIDs in adults and children of any age in Europe and in patients aged 2 years and above in the USA. Typically, Ig20Gly is administered using an infusion pump; however, delivery of Ig20Gly by manual administration has recently been approved in Europe. Practical recommendations on the use of Ig20Gly manual administration are lacking; this review therefore aims to provide guidance for use of this method of administration. Additionally, we summarize the infusion parameters, safety, patient-reported outcomes, and economic benefits associated with Ig20Gly manual administration. Manual administration of Ig20Gly was shown to permit faster rates of infusion than administration via infusion pump. Patients typically infused at two or fewer infusion sites with manual administration of Ig20Gly. Safety and tolerability profiles were similar for Ig20Gly manual administration and administration by infusion pump. Overall, there were comparable levels of patient satisfaction with manual administration and infusion pump, with patient preference deemed to be a key determinator of success for either method of administration. Economic studies identified cost savings for the healthcare system through manual administration compared with IVIG or SCIG infusion by infusion pump because of the reduced equipment costs and nurse support. For infusion of Ig20Gly by manual administration, a syringe and butterfly needle are used; patients are advised to start infusion at 1-2 mL/min to prevent discomfort. Overall, manual administration of Ig20Gly offers an effective and well-tolerated alternative to administration by infusion pump.
原发性免疫缺陷病（PIDs），也被称为先天性免疫缺陷，是一组影响免疫系统的遗传疾病。目前，PID患者的标准治疗方法是通过静脉注射（IVIG）或皮下注射（SCIG）进行终身免疫球蛋白替代治疗。用甘氨酸稳定的20%皮下注射用人免疫球蛋白溶液（Ig20Gly）在欧洲被批准用于任何年龄的成人和儿童PID患者的替代治疗，在美国被批准用于2岁及以上患者。通常，Ig20Gly使用输液泵给药；然而，最近在欧洲，Ig20Gly手动给药已获批准。目前缺乏关于Ig20Gly手动给药的实用建议；因此，本综述旨在为这种给药方法的使用提供指导。此外，我们总结了与Ig20Gly手动给药相关的输注参数、安全性、患者报告的结果和经济效益。结果显示，Ig20Gly手动给药比通过输液泵给药的输注速度更快。使用Ig20Gly手动给药时，患者通常在两个或更少的输注部位进行输注。Ig20Gly手动给药和输液泵给药的安全性和耐受性概况相似。总体而言，手动给药和输液泵给药的患者满意度水平相当，患者偏好被认为是两种给药方法成功的关键决定因素。经济研究表明，与通过输液泵进行IVIG或SCIG输注相比，手动给药可降低设备成本和护士支持成本，从而为医疗系统节省成本。对于Ig20Gly手动给药，使用注射器和蝶形针；建议患者以1-2毫升/分钟的速度开始输注，以防止不适。总体而言，Ig20Gly手动给药是一种有效且耐受性良好的输液泵给药替代方法。
